FDA Drug recall D-0456-2017
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173…
- FDA Drug
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173… by Fresenius Kabi Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0456-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 63323-411-22 |
|---|---|
| ndc | 63323-411-27 |
| ndc | 63323-411-15 |
| ndc | 63323-411-12 |
| ndc | 63323-411-18 |
| ndc | 63323-411-25 |
| ndc | 63323-411-13 |
| ndc | 63323-411-10 |
| ndc | 63323-412-18 |
| ndc | 63323-412-25 |
| ndc | 63323-412-03 |
| ndc | 63323-412-02 |
| ndc | 63323-412-06 |
| ndc | 63323-412-05 |
| ndc | 63323-412-13 |
| ndc | 63323-412-10 |
| code_info | Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0456-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.